SIGMA 2011-03-014Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295081357), received between Jul 24, 2017 and Nov 13, 2023 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE REASSEMBLING TRIAL INSTRUMENTS IT WAS NOTICED THAT A TRIAL THAT WAS BENT AND WOULD NOT FUNCTION PROPERLY. NO ADDITIONAL INFORMATION IS AVAILABLE. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118164 ↗
• MalfunctionMar 16, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT SZ 4 AND 5 TC3 BOX TRIALS BENT AT BOTTOM. PIECE REMOVED AND TOSSED. SCREWDRIVER STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551627 ↗
• MalfunctionMay 7, 2022Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE SIZE 4 TC3 BOX TRIAL WOULD NEVER LOCK INTO PLACE. THE TOP PORTION WOULD CONTINUE TO MOVE AROUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315944 ↗
• MalfunctionAug 3, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE BOX TRIAL IS STRIPPED AND WILL NOT ATTACH TO THE FEMUR TRIAL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268812 ↗
• MalfunctionDec 15, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TC3 BOX INSTRUMENT WOULD NOT SCREW INTO THE FEMORAL TRIAL. NO PIECES WERE BROKEN OFF. INSTRUMENT IS BEING SENT BACK IN ITS ENTIRETY. EVENT DID NOT CAUSE DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11012059 ↗
• MalfunctionMar 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SECURE SCREW BECAME DISASSOCIATED FROM TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9853824 ↗
• MalfunctionFeb 11, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENTS ARE STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9695047 ↗
• MalfunctionJan 10, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN OUT PER CENTRAL STERILE PROCESSING. CSR ASKED FOR REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9575402 ↗
• MalfunctionOct 25, 2019Break; Break

  SCREW CAME OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9238967 ↗
• MalfunctionOct 25, 2019Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PRODUCT WAS STUCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9238543 ↗
• MalfunctionOct 3, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON WAS REAMING WITH THE HUDSON ADAPTOR AND REAMERS THE HUDSON ATTACHMENT AND THE REAMERS STRIPPED AND HAD DIFFICULTY REAMING THE FEMUR AND THE TIBIA. THEY TRIED THIS WITH BOTH SETS OF OUR HUDSON¿S AND T-HANDLES AND REAMERS. ALSO THE SIZE 4 TC3 BOX TRIAL WOULD NOT STAY ON THE FEMUR TRIAL SO THINK THE TORQUE SCREW MUST BE STRIPPED. A SURGICAL DELAY OF 15-20 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 9152457 ↗
• MalfunctionSep 4, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  TECH WAS ATTEMPTING TO PUT TOGETHER THE SIZE 4 TC3 BOX TRIAL ON THE TRIAL FEMUR & WAS UNABLE TO GET THE DEVICE TO LOCK ON PROPERLY. DEVICE APPEARS TO BE STRIPPED & WILL NOT LOCK DOWN. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8962201 ↗
• MalfunctionAug 16, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND BROKEN IN THE OFFICE SET. IT WAS OUT OF TOLERANCE AND NOT USED DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8902904 ↗
• MalfunctionApr 1, 2019Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION OF THE INSTRUMENTS IT WAS NOTICED THAT THERE WAS SOME CRACKING AND BENDING GOING ON WITH THE FEET ON THE NOTCH TRIALS IN THE SIGMA REVISION INSTRUMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470481 ↗
• MalfunctionFeb 19, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE WAS WITH DIFFICULTY WITH A FEW DIFFERENT INSTRUMENTS ON THIS CASE. THE 45MM TIBIAL BROACH WOULD NOT CONNECT WELL WITH THE STEM EXTENSION TRIAL. THE TC FEMORAL BOX TRIAL WOULD KEEP UNSNAPPING OFF THE FEMORAL COMPONENT TRIAL AND WOULDN'T LOCK ON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8350654 ↗
• MalfunctionOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SIZE 4 TC3 BOX TRIAL (201103014/ SO2002017) WAS FOUND BROKEN WHEN OPENING THE TRAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7931942 ↗
• MalfunctionOct 1, 2018Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE BOX WON¿T ENGAGE THE FEMORAL COMPONENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7921793 ↗
• MalfunctionAug 30, 2018Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE SCREW WON¿T THREAD INTO THE FEMORAL TRIAL. ALSO THE SCREW WILL FALL OUT. SALES REPRESENTATIVE THINK IT¿S WORN OUT AND NEED A REPLACEMENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832382 ↗
• MalfunctionMay 10, 2018Bent; Crack; Bent; Crack

  IT WAS REPORTED THAT THE SIGMA BOX TRIAL SIZE 4 AND SIZE 5 MECHANISM THAT TIGHTENS THE BOX TO THE FEMUR TRIAL WAS BENT AND CRACKED. THE BOX TRIAL WOULD NOT FULLY SEAT ONTO THE FEMUR TRIAL. NO PIECES WERE BROKE OFF JUST NEED TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502071 ↗
• MalfunctionApr 12, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT THE SIZE 4 TC3 BOX TRIAL BROKE. NO PATIENT INVOLVEMENT. ALL PIECES WERE RETRIEVED. FRONT PIN THAT CONNECTS WITH TRIAL FEMUR CAME OUT AND COULDN'T BE REATTACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7424769 ↗
• MalfunctionFeb 9, 2018Bent; Bent

  IT WAS REPORTED THAT THE FEET ARE BENT ON BOX TRIAL SO NOT FITTING INTO TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7258859 ↗
• MalfunctionOct 26, 2017Break; Break

  IT WAS REPORTED THAT THE SIZE 4 TC3 BOX ADAPTER BROKE. THE BOTTOM FEET BROKE WHEN THE SCREW WAS TIGHTENED. ALL PARTS WERE RECOVERED.

  Patient problems: No Information

  MAUDE report 6979032 ↗
• MalfunctionJul 24, 2017Break; Break

  IT WAS REPORTED THAT THE SIGMA HP REVISION TC3 BOX TRIAL WAS BROKEN.

  Patient problems: No Information

  MAUDE report 6735928 ↗